CMS Issues Final Rule Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses

On May 23, 2019, CMS issued a final rule regarding Part D expenses and the Agency’s ongoing efforts in lowering the cost of prescription medications for its beneficiaries.

Per the rule, CMS reports that this final rule amends the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to support health and drug plans’ negotiation for lower drug prices and reduce out-of-pocket costs for Part C and D enrollees.

CMS then goes on to outline the major provisions of the new rule. Per the announcement there are 5 provisions that CMS plans to implement. They are as follows:

1.) Providing Plan Flexibility to Manage Protected Classes:

According to CMS, except in limited circumstances, current Part D policy requires Part D sponsors to include on their formularies all Part D drugs in six categories or classes: (1) antidepressants; (2) antipsychotics; (3) anticonvulsants; (4) immunosuppressants for treatment of transplant rejection; (5) antiretrovirals; and (6) antineoplastics. The new proposed rule provides for three exceptions to this protected class policy that would allow Part D sponsors to: (1) implement broader use of prior authorization (PA) and step therapy (ST) for protected class Part D drugs, including to determine use for protected class indications; (2) exclude a protected class Part D drug from a formulary if the drug represents only a new formulation of an existing single-source drug or biological product, and (3) exclude a protected class Part D drug from a formulary if the price of the drug increased beyond a certain threshold. This rule is purported to be effective as of January 1, 2020.

2.) Updates to Part D E-Prescribing Standards

The requirement for this provision is that Part D plan sponsors implement an electronic real-time benefit tool (RTBT) capable of integrating with at least one prescriber’s electronic prescribing (eRx) system or electronic health record (EHR). According to CMS, this would support interactive real-time standards whenever feasible, and for standards that improve the cost-effectiveness of the Part D benefit. This provision would not go into effect until January 1, 2021.

3.) Medicare Advantage and Step Therapy for Part B Drugs

CMS indicated that in this final rule, CMS is reaffirming Medicare Advantage plans’ existing authority to implement appropriate utilization management and prior authorization programs (meaning policies and procedures) for managing Part B drugs to reduce costs for both beneficiaries and the Medicare program.

4.) Part D Explanation of Benefit

With this new rule, CMS is requiring the inclusion of negotiated drug pricing information and lower cost alternatives in the Part D Explanation of Benefits beginning on 01/01/2021. CMS cites its ongoing goal to be more transparent for beneficiaries’ which hypothetically would in turn create more competition and therefore lower costs.

5.) Prohibition Against Gag Clauses in Pharmacy Contracts

This rule also implements the statutory requirement that restricts Part D sponsors from prohibiting or penalizing a pharmacy from disclosing a lower cash price to an enrollee. Again, this is purported to help lower out-of-pocket costs of prescription drugs for Medicare beneficiaries by helping inform them about lower cost alternatives.

In summary, CMS has been actively working towards their agenda of lowering prescription medicines for beneficiaries. However, considering that these rules are set to be enacted in 2020 and some even in 2021, it may be some time before beneficiaries see the benefits of such provisions.

To read the notification in its entirety, the link can be found here.

The Gordon & Rees Medicare Compliance Group will continue to monitor this case and bring you updates as they become available. Please contact me at (412) 588-2283 or rmaldonado@grsm.com should you wish to discuss this or any other Medicare Secondary Payer matters.

ELECTRONIC PAYMENTS VIA MSPRP NOW LIVE

Effective April 1, the Medicare Secondary Payer Recovery Portal (MSPRP) is equipped to accept electronic payments for Medicare conditional payment reimbursements. Answers to common inquiries were subsequently released by CMS on April 12, 2019 called “Electronic Payments on the Medicare Secondary Payer Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP) Frequently Asked Questions and Answers.” Such functionality was originally referenced in the Strengthening Medicare and Repaying Taxpayers (SMART) Act of 2012.

In the alert, CMS specifically indicated that to make an electronic payment through the MSPRP, one does not need a new or updated user access. The option is available to any user on any matter to which the user already has access.

Payments are not required to be made through the MSPRP. Payers may continue to remit a paper check to satisfy Medicare conditional payment demands. However, any refund issued by the Medicare recovery contractor will still be made via paper check and will not be made electronically, to date.

Interestingly, CMS specifically reports that in order to make an electronic payment through the MSPRP, the matter to which you wish to apply payment must be in “demand” status. There is no option to remit payment electronically unless the amount has been demanded. Therefore, if payment is desired to be made on a Conditional Payment Notice instead of a Demand for Reimbursement, a written check still must be mailed to the CRC/BCRC for application to the claim. Furthermore, CMS clarifies that when paying online, this does not mean that the full demand amount must be paid. If a Redetermination Request has been submitted on a portion of the conditional payments being asserted, a user can still submit a partial electronic payment.

Finally, CMS reported that the electronic payments utilize Pay.gov to secure the transaction, where payments can be made utilizing a savings/check account, debit card, or PayPal linked to a bank account. Credit cards, however, are not being accepted for payment at present. Also, the limit for each payment method is posted, as well. Once payment has been made. a confirmation of payment will be posted to the MSPRP on the Payment Status page. Additionally, an Electronic Payment History status will list the status of all electronic payments, as well as the amount and payment date.

In summary, the new electronic payment system appears to streamline the payment process significantly, with much quicker application times and updates to the portal. However, as indicated above, it is still requiring that non-demand claims must be paid via paper check. This can be frustrating for those that are attempting to make payments before the demand and can potentially complicate settlements.

We at Gordon and Rees will continue to monitor these issues and will continue to report any updates.

New Part D Safety Policy Intends to Reduce Opioid Misuse

CMS recently announced its new Medicare Part D opioid safety policy, intended to reduce prescription opioid misuse. One aspect of the new policy is improved safety alerts at the pharmacy for Part D beneficiaries who are filling initial opioid prescriptions or receiving high doses. CMS cited the following three situations that would warrant an alert:

CMS recently announced its new Medicare Part D opioid safety policy, intended to reduce prescription opioid misuse. One aspect of the new policy is improved safety alerts at the pharmacy for Part D beneficiaries who are filling initial opioid prescriptions or receiving high doses. CMS cited the following three situations that would warrant an alert:

• Possible unsafe amounts of opioids.
• First prescription fills for opioids.
• Use of opioids and benzodiazepines at the same time.

CMS reports that if an alert is sent and if the prescription can’t be filled as written, including the full amount on the prescription, the pharmacist will give the beneficiary a notice explaining how they or their doctor can contact the plan to ask for a coverage determination.

The new policy also permits Part D plans to put drug management programs in place to help beneficiaries. One of the proposed ways that a Part D plan would accomplish this is given through the example that if a beneficiary gets opioids from multiple doctors or pharmacies, the beneficiary may be directed to receive such medications from specific providers or pharmacies to avoid overlap. However, the most notable part of this new plan is that the Part D plan will send the beneficiary a letter if it will limit their access to these medications under its drug management program. If so, the beneficiary and their doctor will have the right to appeal.

CMS acknowledges that “one size does not fit all” and that such policies do not apply to specific populations (i.e. long-term care facilities, individuals in hospice, palliative, or end-of-life care). To that end, additional material was provided for prescribers, pharmacists, and patients to clarify CMS’s interpretation of these policies.

Practitioner’s Note: While these policies are admirable in their attempt to curb the opioid issues within our country, it does beg the question as to what impact this will have in a clinical setting. With the example of the seven (7) day fill rule for new opioid users, in a majority of workers’ compensation and/or liability cases the beneficiary isn’t a beneficiary at the time of injury and the initial prescription of pain medication. As such, this policy would not apply to those individuals. Additionally, upon review of the additional materials for the providers and pharmacists, CMS specifically notes in bold “This alert is not a prescribing limit” and explains that decisions to taper or discontinue prescription opioids are individualized between patient and prescriber. How this policy may apply to the current Workers’ Compensation Medicare Set-Aside Reference Guide allocation methodology has yet to be determined.

The Gordon & Rees Medicare Compliance team will continue to follow these trends and update you as new developments arise.

Gordon Rees Scully Mansukhani Becomes First 50-State Law Firm

With 68th office opening, Gordon Rees Scully Mansukhani expands reach, services to every state.

Gordon Rees Scully Mansukhani (GRSM) has opened its 68th office, creating the world’s first 50-state law firm.

Name partner Miles Scully heralded the move as a game-changing moment in the legal services industry. “As the first and only law firm to feature offices in all fifty states, we are poised to meet our clients’ needs whenever or wherever they may arise. Our deep bench of talented lawyers coupled with our forward-thinking use of technology enables us to lead the industry in providing efficient and cost effective representation virtually anywhere in the country.”

Managing partner Dion Cominos added, “With an already established national platform, the firm was well-positioned to take the next step of providing full territorial coverage throughout the United States. This milestone represents both the culmination of our journey toward becoming a truly national firm, and the next chapter in a new era of delivering seamless and comprehensive legal services to clients on a nationwide basis.”

Since its founding 45 years ago in San Francisco, GRSM has strategically expanded across the nation, opening offices in markets critical to its clients. And as the firm’s clients have continued to consolidate, grow in size, and span additional industries, GRSM has grown to match and service their needs – initially on the west coast, and eventually throughout the country. The full list of GRSM’s offices and local contacts can be found here.

The firm’s strong growth was recognized by The American Lawyer in 2018, which named GRSM number 103 in top grossing law firms, moving up seven spots from the previous year. Law360 recognized the firm as the 40th largest in the United States in its annual rankings by domestic attorney headcount. The firm was also recognized among the top 45 for diversity on The American Lawyer Diversity Scorecard.

GRSM is a national litigation and business transactions firm with more than 900 lawyers providing full service representation to public and private companies ranging from the Fortune 500 to start-ups. Founded in 1974, GRSM is recognized among the fastest growing and largest law firms in the country.

Highlights of Resulting Media Coverage:
Bloomberg Law, April 15, 2019
Law360, April 15, 2019 (subscription may be required)

Contacts
Dion N. Cominos
Miles D. Scully

More Webs in Alabama: District Court Quotes Scott, Dismisses MSPA Claim

A recent determination against Infinity Property and Casualty Group emerging from a federal district court in Alabama demonstrates that while so many MSPA private cause of action claims pose similar legal shortcomings, the courts have no shortage of colorful ways to dismiss them.

Quoting the famous words of Sir Walter Scott, the Opinion opens with “Oh! what a tangled web we weave / When first we practice to deceive!” Dismissing with prejudice MSPA Claims I, LLC’s latest efforts, the U.S. District Court for the Northern District of Alabama, Southern Division determined on March 19 that subject matter jurisdiction did not exist, thwarting its attempt to “catch a lucrative class action lawsuit under the Medicare Secondary Payer statue.” MSPA v Infinity Prop & Casualty Group, 2019 U.S. Dist. LEXIS 43620 (2019).

In this case, two separate automobile accidents occurred in which Infinity was the insurance carrier. Medicare beneficiary D.W was enrolled in Part C through Florida Healthcare Plus, Inc. and Medicare beneficiary B.G. was enrolled in Part C through Simply Healthcare Plans, Inc., both of which Plaintiff alleged assigned to it rights under the Medicare Secondary Payer laws to recover medical payments Infinity failed to reimburse.

With regard to D.W., Infinity disputed MSPA’s allegations on the grounds that Infinity had no obligation to pay the FHCP bill of $140.47 as it properly paid all of D.W.’s medical bills with additional medical coverage still available. FHCP assigned its recovery rights to La Ley Recovery Systems in 2014. According to the agreement. La Ley could not assign those rights to a third party without the approval of FHCP’s (or the Florida Department of Financial Services later through receivership).

La Ley attempted to reassign these rights to MSPA in 2015 without approval. While approval was later granted at the time of settlement on June 1, 2016, the court decided the assignments were valid but that FHCP never had standing to bring a claim under the MSP in the first place and FHCP never suffered an injury in fact.

With regard to B.G., the medical coverage with Infinity exhausted. InterAmerican Medical Center Group, LLC served as Simply’s Management Service Organization (MSO). In a tapestry of alleged assignments, Plaintiff claimed Simply contractually assigned recovery rights to InterAmerican, which were in turn assigned to MSP Recovery, LLC, and as “the final strand in its web…” MSP Recovery assigned those rights to Plaintiff.

The Court dismissed the allegations on the grounds that the statute affords recovery rights to MOAs but there is no clear indication that MSOs have these statutory rights.

The Court pointed out “fatal” defects in Plaintiff’s web of assignments, ultimately granting Defendant’s motion for summary judgment due to lack of standing.

Elsewhere on the very same day, the 11th Circuit Court of Appeals was busy exterminating another MSPA private cause of action claim. Somehow on the same page with the Alabama court in both legal and literary senses, the 11th Circuit Court wove the web theme into its dismissal. See MSP Recovery Gets Caught in the Tangled Web of the Medicare Secondary Payer Act.

Given the growing body of dismissals, it should be interesting to see how future courts rule on such actions going forward. To discuss this case or other Medicare Secondary Payer matters, please contact Michelle Allan at (412) 588-2289 or mallan@grsm.com.

MSP Recovery Gets Caught in the Tangled Web of the Medicare Secondary Payer Act

In the recent case of MSPA Claims 1, LLC v. Tenet Fla., Inc. the Eleventh Circuit Court of Appeals affirmed the holding of the district court, dismissing a case for recovery of payments under the private cause of action of the Medicare Secondary Payer Act (MSP Act). While aspects of the MSP Act can be very convoluted and confusing, especially with regard to the private cause of action for recovery of primary payments, the court here begins its opinion by stating “Luckily, we do not need to venture very far into its tangled web here. The provision at issue in this case is clear, and clearly bars plaintiff’s claim.” See MSPA Claims 1, LLC v. Tenet Fla., Inc. 2019 U.S. App. LEXIS 7833.

The court here spends little time examining the makeup and history of the MSP Act; however, reminds us that while the Act has created a private cause of action that permits the government to sue when it is not properly reimbursed by a primary payer, it also provides for a private cause of action for private plaintiffs to recover double damages. The intent of this private cause of action is to encourage private parties to enforce Medicare’s right of recovery against primary payers in the courts. See generally MSPA Claims 1, LLC v. Tenet Fla., Inc. 2019 U.S. App. LEXIS 7833. Various courts have held this private cause of action to extend to Medicare Advantage Organizations (MAOs).

While a detailed rehashing of the facts of this case is not important to understanding the outcome, a brief background will help outline the issue here. In short, one of Florida Healthcare Plus’s (an MAO) enrollees was involved in a car accident and received medical care at St. Mary’s Medical Center. St. Mary’s billed both the enrollee’s primary plan- Allstate, as well as FHCP. FHCP assigned its right of recovery to the Plaintiff in this case MSPA Claims 1, LLC, through a series of assignments. St. Mary’s later reimbursed FHCP in full- $286. However, MSPA Claims brought suit against ST. Mary’s and its parent company Tenet Florida, Inc. for the delayed $286 reimbursement.

The court here determined that FHCP did suffer an injury-in-fact and that MSPA Claims has standing to bring the case and therefore the case was properly in court; however, in order to survive dismissal, the claim must still be plausible. The court reiterates that the MSP Act’s private cause of action is only available in the case in which a primary plan fails to reimburse Medicare, or in this case an MAO. Here, MSPA Claims has sued a medical service provider and not a primary plan. The court reasoned that given the fact that MSPA Claims has not sued a primary plan, its claim is not plausible on its face, and therefore the dismissal based on failure to state a claim issued by the lower court is affirmed.

This dismissal provides another instance of MSP Recovery, LLC getting caught in the tangled web that is the Medicare Secondary Payer Act. The amount in controversy here hints that the purpose of bringing this case was to attempt to gain a favorable decision and to begin to carve a path through the case law to further recovery by MAOs under this provision of the MSP Act. While the private cause of action at issue here is a dangerous one given the double damages provision, this case makes it clear that there is still work to be done in order to weave through this tangled web.

United States Sues Plaintiff Attorney, Medicare Beneficiary, and the Insurer for Conditional Payments in the Middle District of Pennsylvania

On February 26, 2019, the Middle District of Pennsylvania addressed a summary judgment motion brought by the United States against parties to a liability claim that involved a Medicare beneficiary and outstanding conditional payment liens.


The relevant background of the case is that a Medicare beneficiary (Beneficiary) was mistakenly given a medication from a pharmacy which resulted in a sixty-six day hospital stay. During this stay, the Beneficiary incurred nearly $100,000 in treatment bills. As the Beneficiary’s insurer, Medicare paid these bills, of which $84,353 was found to be related to the administration of the mistaken medication. The Beneficiary then filed a lawsuit against the pharmacy and medical care center, represented by Richard Angino of Angino Law Firm (“the Angino Defendants”). During settlement of the claim, the Angino Defendants requested the amount of charges that were paid by Medicare for the associated injury. The Centers for Medicare & Medicaid Services (CMS) reported back that $1,212 was paid. This was the amount that was ultimately relied upon at settlement.
As is the procedure, upon notification of settlement, CMS issued a demand of $84,353.00, but reduced it to $53,295.00, accounting for attorney’s fees. CMS also notified the Angino Defendants and the Beneficiary this amount was due in sixty (60) days. This amount was never paid.


CMS then filed a lawsuit under the Medicare Secondary Payer Act, 42 U.S.C § 1395(b)(2)(B) that as a matter of law it was entitled to $84,35.00 plus interest. A motion for summary judgement was filed by the defense. During this time, the Beneficiary passed away and in a separate action, the Beneficiary’s estate challenged the $84,353.00 and asserted that CMS was only due the $53,295.00. However, the lower court found that it did not have jurisdiction. Thus, the Plaintiff argued that Defendants lost their challenge and therefore owe the full $84,353.00. Defendants rebutted this argument on the grounds that although they cannot appeal the lower amount, they can challenge the $84,353.00. Additionally, Defendants claim questions of fact exist as to who would be responsible for payment of any potential excess owed.


Of note, the Defendants set aside the $53,295.000 and attempted to settle the conditional payments. However, CMS pursued litigation and increased the amount owed. As such, the Court agreed that a question of fact existed as to whether or not the Plaintiff had to pursue litigation to collect the amount due and justify raising the amount due. Plaintiff countered that the law provides that where Medicare “must file suit” to recover on the lien, they need not deduct attorney’s fees from the lien amount. 42 C.F.R. § 411.37(e). The Court responded that “at least with the facts which we are presented with, that whether or not the plaintiff had to pursue litigation is a question of fact.” (United States v. Angino, 2019 U.S. Dist. LEXIS 30499 (February 26, 2019).


As such, the Court found genuine issues of material fact and the summary judgement motion denied.


Practioner’s Note: This case is a reminder of the trouble parties can get into when not properly addressing the conditional payment liens associated with a liability claim. Remembering Shapiro v. Secretary of Department of Health & Human Services, 2017 U.S. Dist. LEXIS 42278 (March 23, 2017), the 2017 case mirrors the fact pattern at hand, in that the Beneficiary cannot rely upon the interim lien amount and Medicare is entitled to the final conditional payment amount issue after settlement of a claim.

Interestingly, this case has yet to determine who ultimately will be responsible for any excess payments over the $53,295.00. Also worth note, the Beneficiary’s estate, the Beneficiary’s attorney, and the Carrier were all parties to this action. This particular question could potentially have been avoided if only proper settlement language would have been included clarifying which party would be responsible for any overage. This is yet another prompt that settlement language continues to be an important piece to the settlement puzzle.


The Gordon & Rees Medicare Compliance Group will continue to monitor this case and bring you updates as they become available. Please contact me at (412) 588-2283 or rmaldonado@grsm.com should you wish to discuss this or any other Medicare Secondary Payer matters.

CMS Announces Webinars for Upcoming Enhancements to the Medicare Secondary Payment Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP)

CMS  announced two webinars for Upcoming Enhancements to the Medicare Secondary Payment Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP).

More to the point, the webinars will be addressing the fact that that effective April 1, 2019, electronic payment functionality will be added to both the MSPRP and the CRCP.  Taking place on March 13, 2019 for MSPRP users and March 14, 2019 for CRCP users, the webinars will provide more information on this new feature.

Practitioner’s Note: This enhancement could make paying outstanding Medicare conditional payments so much easier for debtors. Instead of sending a check and ensuring it’s applied to the proper claim, this function will hopefully give payers assurance that payment has been received and applied in a prompt manner and cut down on error when applying payments to claims that are not in final demand status. Additionally, it may be interesting to see how this may impact refunds as well.

The Gordon & Rees Medicare Compliance team will continue to follow these trends and update you as new developments arise.

Medicare Coverage App Launches eMedicare

Yesterday CMS announced a new app to display what Medicare Part A & B covers. Per the announcement, “The new ‘What’s Covered’ app lets people with Original Medicare, caregivers and others quickly see whether Medicare covers a specific medical item or service. Consumers can now use their mobile device to more easily get accurate, consistent Original Medicare coverage information in the doctor’s office, the hospital, or anywhere else they use their mobile device.” Unsurprisingly, CMS discussed the need for this app as questions about what Medicare covers are some of the most frequent inquiries that CMS receives.

Interestingly, this app also is reported to enable beneficiaries to connect their claims data to applications and tools developed by innovative private-sector companies to help them understand, use, and share their health data.

As discussed previously, this innovation is in line with the directive from the current administration to move toward more electronic access in regards to healthcare. Specifically, this program is called eMedicare, and some of the purported goals are to allow beneficiaries to examine all available plans and see how different coverage choices will affect out-of-pocket costs.

Practitioner’s Note: This app could be extremely beneficial to beneficiaries who have had a MSA approved and are attempting to appropriately spend down their funds. Additionally, it will be interesting to see if the next version of this new app will include the option to compare Part C plans. Considering the narrative, ease of comparing different Part C plans appears to be an important part of the eMedicare program. However, this does beg the question what exactly is the “health data” they aim to share? 

The Gordon & Rees Medicare Compliance team will continue to follow these trends and update you as new developments arise.

The Ghost of Cases Past – MSPA Claims LLC, v. Scottsdale Insurance Co.

For those familiar with the slew of MSP Recovery cases that have been ruled upon in the past six (6) months, it will come as no surprise that another court, specifically the United States District Court for the Southern District of Florida, found that MSPA Claims LLC lacked standing when bringing suit against the Defendant.

Echoing the recently decided cases brought by MSP Recovery and its subsidiaries, the Court again in MSPA Claims v. Scottsdale Insurance found that Plaintiff lacked standing as proof of assignment of rights was not present and as such, granted Defendant’s motion for dismissal. Facts that are almost identical to MSPA Claims 1, LLC v. Ocean Harbor and MSPA Claims 1, LLC. v United Auto. Ins. Co., 204  F. Supp. 3d 1342, 1345 (S.D. Fla. 2016), Plaintiff asserted rights were assigned from Florida Healthcare Plus to La Ley Recovery which then assigned rights of recovery to MSP Recovery. The Court disagreed and specifically noted that although Plaintiff argued Florida Healthcare Plus approved assignment to La Ley to MSPA Claims, prior to receivership, the assignment did not predate the receivership. More pointedly, the Court stated it “is unclear how Florida Healthcare Plus could have approved the assignment…valid if MSP Claims was not yet formed as a company in 2014 when the receiver took over Florida Healthcare Plus[1].”

As such, the Court granted Defendant’s motion for dismissal without prejudice.

With yet another ruling dismissing a claim brought by MSP Recovery, the Floridian courts appear to sharpen their scrutiny regarding cases brought by assignees of rights by Medicare Advantage Plans. The pressing question however, is will other jurisdictions look to these cases as persuasive case law in their own courts? The Gordon Rees Medicare Group will continue to monitor these cases and bring you updates as they become available.


[1] MSPA Claims 1. LLC v. Scottsdale Ins. Co., 2018 U.S. Dist. LEXIS 218675